Brand name prescribing status for Tacrolimus products updated on dm+d
Following representation from PSNC, the NHS Business Services Authority (NHSBSA) has added the ‘Caution – AMP level prescribing advised’ marker to oral Tacrolimus products on the Dictionary of medicines and devices (dm+d). This is in line with the MHRA guidance that oral Tacrolimus products should be prescribed and dispensed by brand name only, to minimise the risk of inadvertent switching between products, which has been associated with reports of toxicity and graft rejection. The following Oral Tacrolimus Virtual Medicinal Products (VMPs) are now also flagged as ‘Caution – AMP level prescribing advised’:
- Tacrolimus 500microgram modified-release capsules
- Tacrolimus 1mg modified-release capsules
- Tacrolimus 3mg modified-release capsules
- Tacrolimus 5mg modified-release capsules
NHSBSA noted that the reason for not flagging all Oral Tacrolimus VMPs is explained on page 22 of their NHS dm+d Editorial Policy: ‘where only one licensed AMP is/has been available and the VMP has an ‘approved’ generic name, then that product should not be marked with ‘Caution – AMP level prescribing advised’.
To support brand name prescribing (Actual Medicinal Product (AMP) level prescribing – see additional information below) of certain drugs in line with guidance issued by MHRA/SPS/BNF, PSNC has requested addition of the ‘Caution – AMP level prescribing advised’ marker on dm+d to other products that are required / recommended for prescribing by brand. For example, Primidone 50mg tablets does not have the ‘Caution-AMP level prescribing advised’ marker. PSNC is awaiting a decision from NHSBSA on these.
The dm+d is structured around four key components: Virtual Medicinal Product (VMP), Actual Medicinal Product (AMP), Virtual Medicinal Product Pack (VMPP) and Actual Medicinal Product Pack (AMPP).
The Virtual Medicinal Product (VMP) describes the generic title for a product including the form and strength, for example ‘Tacrolimus 1mg modified-release capsules’.
The Virtual Medicinal Product Pack (VMPP) describes the generic title for a generic or proprietary product pack which is known to have been available. The description includes the pack size, for example ‘Tacrolimus 1mg modified-release capsules 50 capsule’.
The Actual Medicinal Product (AMP) describes an actual product which is known to have been available linked to the name of a particular supplier, for example ‘ Advagraf 1mg modified-release capsules (Astellas Pharma Ltd)’.
The Actual Medicinal Product Pack (AMPP) describes an actual product which is known to have been available linked to both the name of a particular supplier and information on the pack size of the product, for example ‘Advagraf 1mg modified-release capsules (Astellas Pharma Ltd) 50 capsule 5 x 10 capsules’.
Linked to each component, the dm+d also includes information to support the prescribing and dispensing process, for example linked to the ‘Actual Medicinal Product Pack’ component there are a range of attributes detailed such as the product’s legal category and confirmation of whether a product is considered a special container or calendar pack. This information is populated by NHSBSA.